The Yosomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needles are used by peeling back the peel tab and snapping the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the insulin is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Clickfine Pen Needle

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Standard/Regulation	Reported Device Performance
Pen-injector requirements (Needles)	ISO 11608-2:2000	Met the requirements of relevant sections of the standard.
Stainless steel needle tubing	ISO 9626:1991/Amd.1:2001	Met the requirements of relevant sections of the standard.
Sterile hypodermic needles for single use	ISO 7864:1993	Met the requirements of relevant sections of the standard.
Biological evaluation of medical devices	ISO 10993-1:2003	Met the requirements of relevant sections of the standard.
Puncture resistance of outer cap	Internal Protocol	Equivalent to Unmodified Device.
Seal Integrity of Sterile barrier	Internal Protocol	Equivalent to Unmodified Device.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the exact sample sizes used for each of the tests. The studies involved testing the Ypsomed Clickfine Pen Needles against various international and internal standards and protocols.

The data provenance is from Ypsomed AG, a company based in Switzerland, indicating that the testing was conducted by or under the supervision of the manufacturer. The studies are assumed to be prospective, as they were conducted to demonstrate compliance and equivalence for the modified device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies were based on compliance with established international and internal standards, which typically have predefined objective criteria for evaluation rather than relying on expert consensus for ground truth on a case-by-case basis.

4. Adjudication Method for the Test Set

This information is not explicitly stated. Given that the acceptance criteria are based on compliance with international and internal standards, the adjudication would likely involve direct measurement and comparison against predefined thresholds or specifications outlined in those standards, rather than an expert adjudication method like 2+1 or 3+1.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is a physical medical device (pen needle), and its performance evaluation focuses on physical, mechanical, and biological properties, not on interpretation by human readers.

6. If a Standalone Performance Study Was Done

Yes, standalone performance studies were done. The "Performance and Safety Data" section explicitly states that Ypsomed "performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices." This implies that the device's performance was evaluated independently against established criteria in these standards.

7. The Type of Ground Truth Used

The ground truth used for these studies was based on the requirements and test methods specified in the cited international standards (ISO 11608-2, ISO 9626, ISO 7864, ISO 10993-1) and internal protocols. These standards define objective, measurable criteria for the performance, safety, and biological compatibility of pen needles. For example, "puncture resistance" and "seal integrity" would have quantifiable thresholds or specifications within these standards or internal protocols that the device's measurements needed to meet.

8. The Sample Size for the Training Set

This information is not applicable and is not provided. The Clickfine Pen Needle is a physical medical device, not an algorithm or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. The device is a physical medical device and does not utilize a training set in the way AI or machine learning models do.

Summary

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Summary of Safety and Effectiveness

NOV 2 3 2010

"510(K) SUMMARY"

Submitted By/Contact Person:	Dr. Manfred Mäder
	Senior Vice President
	Quality Management & Regulatory Affairs
	Ypsomed AG
	Brunnmattstrasse 6
	CH - 3401 Burgdorf
	Switzerland
	Tel. 0041-344244111
	Fax 0041-344244122
	E-mail: manfred.maeder@ypsomed.com

Date Prepared: August 20, 2010

Clickfine Pen Needle Trade/Proprietary Name: 7.1
7.2 Common/Usual Name:

Injection Pen Needle

7.3 Classification Name:
Hypodermic single lumen needle
7.4 Classification: FDA has classified Hypodermic single lumen needles in Class II. Final Order was published in the Federal Register on October 21, 1980 after review by the General Hospital and Personal Use Devices Classification Panel.
Panel: 80 Procode: FMI
7.5 Purpose of Submission: To establish the substantial equivalence of the modified Y psomed Clickfine Pen Needles to the Disetronic Penfine Insulin Injection Pen Needles.
Substantial Equivalence: The Ypsomed Clickfine Pen Needles are substantially equivalent to the Disetronic Penfine Injection Pen Needles (K994197). The equivalence is supported by the attached documentation.
7.6 Device Description
The Yosomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needles are used by peeling back the peel tab and snapping the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over

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the needle until the insulin is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.

7.7 Intended Use
The intended use of the modified device remains the same as the predicate device (Disetronic Penfine Injection Pen Needles, K994197):

The Ypsomed Clickfine Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injection pen.

7.8 Technological Characteristics The technological characteristics have not changed.

7.9 Performance and Safety Data
Y psomed has performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices.

The Clickfine Pen Needles have met the requirements of the relevant sections of the following standards:

ISO 11608-2:2000 Pen-injectors for medical use -- Part 2: Needles Requirements . and test methods
ISO 9626:1991/Amd.1:2001 Stainless steel needle tubing for the manufacture of . medical devices
ISO 7864:1993 Sterile hypodermic needles for single use .
ISO 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation . and testing
. Puncture resistance of outer cap - Equivalent to Unmodified Device
Seal Integrity of Sterile barrier Equivalent to Unmodified Device ●

The verifications have shown evidence that the Clickfine Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product.

7.10 Conclusion

Ypsomed AG concludes based on the information presented that the modified product is substantially equivalent to the current product legally marketed in the USA.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Manfred Mader Senior Vice President Quality Management & Regulatory Affairs YPSOMED AG Brunnmattstrasse 6 Burgdorf Switzerland CH-3401

NOV 2 3 2010

Re: K102108

Trade/Device Name: Clickfine Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: October 27, 2010 Received: November 4, 2010

Dear Mr. Mader:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Mader

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely, yours,

Hiens J. Roberts

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use

NOV 2 3 2010

510(k) Number (if known):

Device Name:

Indications For Use:

Clickfine Pen Needle

K102108

The Clickfine pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ion (ODE)

Ald C. Chape 11/22/20

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K102108

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).